This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus (HCV) therapy with grazoprevir/elbasvir, will be feasible for the treatment of People who inject drugs (PWID) with recent injecting drug use or people receiving opioid substitution therapy and chronic HCV genotype 1 or 4 infection.
A prospective, observational cohort design will be used to enrol patients attending tertiary, drug and alcohol and primary health care services in Sydney, Australia. The study consists of a treatment phase (12 weeks) and a follow-up phase (up to 3 years) where participants will be followed every 3 months for the first year and every 6 months in years 2-3 to evaluate treatment response and reinfection. The effectiveness of the treatment will be assessed by looking at the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following therapy with grazoprevir/elbasvir and evaluate demographic and clinical predictors of non-response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Grazoprevir/elbasvir (100mg/50mg) once daily for 12 weeks.
Kirketon Road Centre
Darlinghurst, New South Wales, Australia
St Vincent's Hospital
Darlinghurst, New South Wales, Australia
The Langton Centre
Darlinghurst, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12)
Number with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following 12 weeks of daily grazoprevir/elbasvir (100mg/50mg)
Time frame: 12 weeks post treatment
Number of Participants With Treatment Completion
Number who completed HCV treatment as prescribed (12 weeks of grazoprevir/elbasvir (100mg/50mg) daily)
Time frame: 12 weeks from treatment administration
End of Treatment Response (Negative HCV RNA at the End of Treatment)
Number with undetectable HCV RNA at end of treatment following 12 weeks of daily Grazoprevir/Elbasvir (100mg/50mg)
Time frame: 12 weeks from treatment administration
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Drug and Alcohol Clinical Services (Hunter)
Newcastle, New South Wales, Australia